FDA Product Code INI: Vehicle, Motorized 3-wheeled
Three-wheeled motorized vehicles provide enhanced outdoor mobility for people with physical disabilities. FDA product code INI covers motorized three-wheeled mobility vehicles cleared as medical devices.
These scooter-style devices use a battery-powered motor and tiller steering to provide independent mobility for individuals who can sit upright but cannot walk distances. They offer greater stability on uneven terrain than four-wheeled scooters due to their turning radius.
INI devices are Class II medical devices, regulated under 21 CFR 890.3800 and reviewed by the FDA Physical Medicine panel.
Leading manufacturers include Wu'S Tech Co., Ltd., Heartway Medical Products Co., Ltd. and Pride Health Care, Inc..
351
Total
351
Cleared
119d
Avg days
1982
Since
Growing category -
34 submissions in the last 2 years
vs 17 in the prior period
Review times increasing: avg
136d
recently vs 117d historically
FDA 510(k) Cleared Vehicle, Motorized 3-wheeled Devices (Product Code INI)
351 devices
Cleared
Aug 10, 2026
Mobility Scooter (W3465, W3902 (S50 Carbon))
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
Physical Medicine
209d
Cleared
Aug 10, 2026
Mobility Scooter (W3483, W3483A)
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
Physical Medicine
201d
Cleared
Jul 14, 2026
IERO Mobility Scooter (IERO-01)
Jochu Technology Co., Ltd.
Physical Medicine
90d
Cleared
Jul 07, 2026
Mobility Scooter (R200)
Yongkang Ruihe Metal Product Co., Ltd.
Physical Medicine
89d
Cleared
Jun 08, 2026
Virgo Mobility Scooter (Virgo-D,Virgo-F)
Jiangsu Intco Medical Products Co., Ltd.
Physical Medicine
252d
Cleared
Jun 03, 2026
Scooter (YD-03)
Yurob Rehabilitation Medical Co., Ltd.
Physical Medicine
197d
Cleared
May 20, 2026
Mobility Scooter (Air Carbon)
Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.
Physical Medicine
76d
Cleared
Apr 22, 2026
Mobility Scooter (X-12, X-14, X-17)
Wuyi Aichi Industry and Trade Co., Ltd.
Physical Medicine
86d
Cleared
Mar 17, 2026
Electrical Scooter (SM4226)
Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd.
Physical Medicine
194d
Cleared
Mar 12, 2026
Power Mobility Scooter (MJMA01, MJMA02)
Nanjing Mijo Technology Co., Ltd.
Physical Medicine
93d
Cleared
Feb 23, 2026
Mobility Scooter (CL-Q3, CL-Q4)
Zhejiang Wei Ling New Energy Technology Co., Ltd.
Physical Medicine
96d
Cleared
Feb 18, 2026
Mobility Scooter (S3)
Shenzhen Zhimahuaerkai Technology Co., Ltd.
Physical Medicine
91d
Cleared
Jan 29, 2026
Electric Scooter (DDF100)
Zhejiang Nysin Medical Co., Ltd.
Physical Medicine
191d
Cleared
Jan 29, 2026
Electric Scooter (Mojo-T580)
Dongguan Smarfody Mobility Technology Co., Ltd.
Physical Medicine
184d
Cleared
Jan 29, 2026
Electric Scooter (Mojo-T330)
Dongguan Smarfody Mobility Technology Co., Ltd.
Physical Medicine
184d
Cleared
Jan 09, 2026
Mobility scooter (Air Classic)
Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.
Physical Medicine
108d
Cleared
Jan 02, 2026
Mobility Scooter (BC-MS310)
Ningbo Baichen Medical Devices Co., Ltd.
Physical Medicine
120d
Cleared
Dec 23, 2025
Electric Scooter (S202572J, S2060, M2089, S2050)
Guangdong Prestige Technology Co., Ltd.
Physical Medicine
109d
Cleared
Dec 04, 2025
Mobility Scooter (T5)
Zhejiang Taotao Vehicle Co., Ltd.
Physical Medicine
111d
Cleared
Nov 21, 2025
Powered Mobility Scooter (PMS105, GUT177, GCAT047)
Intradin (Shanghai) Machinery Co., Ltd.
Physical Medicine
98d
Cleared
Oct 06, 2025
Folding Mobility Scooter (KD101)
Nanjing Kangni Smart Technology Co., Ltd.
Physical Medicine
59d
Cleared
Sep 30, 2025
Mobility Scooter (BBR-Q40-01)
Jiangsu Bangbang Intelligent Technology Co., Ltd.
Physical Medicine
110d
Cleared
Jul 22, 2025
Mobility Scooter (MS160C)
Suzhou Master Machinery Manufacturing Co.,Ltd
Physical Medicine
54d
Cleared
Jun 18, 2025
Mobility Scooter (JT10)
Jiangxi Jiangte Electric Vehicle Co., Ltd.
Physical Medicine
261d
About Product Code INI - Regulatory Context
510(k) Submission Activity
351 total 510(k) submissions under product code INI since 1982, with 351 receiving FDA clearance (average review time: 119 days).
Submission volume has increased in recent years - 34 submissions in the last 24 months compared to 17 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - INI Product Code
Recent submissions under INI have taken an average of 136 days to reach a decision - up from 117 days historically. Manufacturers should account for longer review timelines in current project planning.
INI devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →